Inclusion Criteria:
To be eligible for study entry participants must satisfy all of the following criteria:
1. Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of
≥ 4 on the Distress Thermometer.
2. Screening HAM-A Score ≥18 (moderate anxiety).
3. Adults aged 18 to 80 years (inclusive) at screening.
4. Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and
a minimum life-expectancy of 6 months in the opinion of the treating physician, with
performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
performed at screening.
5. Agrees not to commence any new psychiatric medications or psychotherapies from
Screening to Week 10.
6. Able to communicate well and follow study procedures, judged as sufficiently
competent with the English language by the investigator, able to build adequate
rapport with study staff.
7. Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and
the opinion of a research team psychiatrist.
8. Be medically suitable in the opinion of the investigator as determined by screening
for medical problems via a personal interview, a medical questionnaire, a physical
examination, an electrocardiogram (ECG), and blood tests.
9. Have access to a device that is compatible to use the digital technology, i.e
smart-phone device tablet.
10. Agree not to take any sedating medications for a minimum of 12 hours before the
dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and
zolpidem. Medications for cancer-related pain are permitted.
11. Must be willing and able to refrain from smoking throughout the duration of the
dosing session. Nicotine replacement therapies may be permitted with the agreement
of the medical monitor.
12. Agree that for 1 week before the psilocybin dosing session, participants will
refrain from taking any illegal drugs or non-prescription medication (including
cannabis, or CBD or THC containing products), nutritional supplement, or herbal
supplement except when approved by the study investigators. Additionally, agree not
to take any form of psilocybin outside of the study, including microdosing, from
baseline through Day 70/Week 10 (Visit 11).
13. Participants taking any other medication that is not explicitly detailed as an
excluded medication will be discussed with the investigator and medical monitor as
appropriate. Decisions on inclusion will be based on clinical judgement and with
sufficient justification provided.
Exclusion Criteria.Participants will be excluded from the study if one or more of the following criteria are
applicable:
Psychiatric
Exclusion Criteria:
1. Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed
independent from the cancer diagnosis, current or past diagnosis of schizophrenia,
psychotic disorder, unless this was resulting from a medical condition (e.g. lupus
or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid
personality disorder, schizoaffective disorder, borderline personality disorder,
anti-social personality disorder or judged to be incompatible with establishment of
rapport or safe exposure to psilocybin, as determined using clinical judgement of
past and present medical and psychiatric history by any specialist psychiatrist or
registered medical professional under the authorized delegation of a specialist
psychiatrist.
2. First-degree relative with a diagnosed psychotic disorder.
3. Scores from the screening psychiatrist (or registered medical professional under the
authorized delegation of a specialist psychiatrist) and baseline (S-STS) that
indicate that the participant is of clinically significant risk of suicide. A
decision will be formed based on S-STS scores and used in combination with other
clinically significant data at screening. Sites should refer to the medical monitor
if required.
4. Has attempted suicide in the twelve months preceding the screening visit.
5. Current (< 1 year) alcohol or drug misuse as identified as moderate or severe during
screening in accordance with Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) criteria, using the MINI 7.0.2, not able or willing to abstain from alcohol
consumption in the period 12 hours prior to the dosing session.
6. Any other reason that might prevent a participant from engaging in therapeutic
preparation and integration sessions.
7. Anyone who has taken a microdose of psilocybin within 5 days of baseline, taken a
higher dose of psilocybin (e.g., dried mushrooms or capsules) within 30 days of
baseline and experienced euphoria, hallucinations, or altered mental status, or used
any classic psychedelics (LSD, ibogaine, ayahuasca, DMT, mescaline) within 3 months
prior to baseline.
Medical
Exclusion Criteria:
1. Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction
or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or
uncontrolled diabetes mellitus or insipidus.
2. Currently taking or planning to take any of the following: any typical or atypical
antipsychotic and monoamine-oxidase inhibitors. Participants with prior use of these
medications must be willing to discontinue their use for at least 2 weeks prior to
the baseline visit and to Day 28.
3. Currently taking or planning to take any anticonvulsant or mood stabilizer,
including carbamazepine, lithium, phenytoin, and valproate. Participants with prior
use of these medications must be willing to discontinue their use for at least 1
week prior to the baseline visit and to Day 28.
4. Any form of fungal allergy.
5. Positive pregnancy test at screening, women who are breastfeeding or of childbearing
potential who are unwilling or unable to use an effective form of contraception (or
abstinence) for the study period and for 1 month post PEX010 dose will be excluded.
Women will be required to conduct a serum pregnancy test at the in-person screening
visit and urine test prior to dosing session. Male participants who do not agree to
use contraception for the study period and for 90 days post PEX010 dose to mitigate
the risk of pregnancy will also be excluded. Note: Refer to Section 4.3.2.1 for
further details about contraception.
6. A diagnosis of epilepsy or at significant risk of seizures based on medical history.
7. Cardiovascular conditions including stroke and/or myocardial infarction (less than
one year before providing informed consent), uncontrolled hypertension (blood
pressure > 140/90 mmHg) or clinically significant arrhythmia at screening. Results
are exempt if they are a direct result of the participant's cancer diagnosis and do
not present a risk to administration of psilocybin, following discretion of the
investigator.
8. Anyone who, at screening, has clinically significant findings on physical
examination, including resting vital signs (HR below 40 or above 120 bpm, blood
pressure below 90/60 or above 140/90), ECG (QTcF > 450 msec for males and >470 for
females), and positive alcohol breath test. Note: Inclusion of individuals with any
out-of-range values, including blood pressure, is at the discretion of the
Investigator.
9. Liver dysfunction at screening as defined by AST and/or ALT > 1.5 times the upper
level of normal or upper reference range. Results are exempt if they are a direct
result of the participant's cancer diagnosis and do not present a risk to the
administration of psilocybin, following discretion of the investigator.
10. Renal Function: estimated glomerular filtration rate <60 mL/min (calculated using
Chronic Kidney Disease Epidemiology Collaboration) unless this is a direct result of
the cancer diagnosis and does not present a risk to the administration of
psilocybin, following the discretion of the investigator.
11. Any clinically significant laboratory abnormality(s) that in the opinion of the
investigator would present a risk to the administration of psilocybin.
12. Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other
illness that could affect the interpretation of results or be a potential health
risk for the person if they were to be included in the study. Results are exempt if
they are a direct result of the participant's cancer diagnosis and do not present a
risk to administration of psilocybin, following discretion of the investigator.
13. Below 18 or above 32kg/m2 Body Mass Index (BMI) score at Screening.
14. Anyone with organic brain injury or diagnosed with any cognitive impairment.
15. Positive urine drug test for non-prescribed psychoactive substances at the dosing
session visit. Positive urine drug test for psychoactive substances at the in-person
screening should be referred to the medical monitor. Note: Testing may be repeated
once at the discretion of the Investigator.
16. Anyone on a research study of an investigational drug or who has been on a clinical
trial within 3 months of enrolment.
